FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HYDROXYPROGESTERONE BY RIA 17A
K Number: K840886
·
Decision Apr 18, 1984
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
56
Applicant Total
15
Review Days
51
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Basic Information
- Device Name
- HYDROXYPROGESTERONE BY RIA 17A
- K Number
- K840886
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1620
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Radioassay Systems Laboratories, Inc.
- Date Received
- February 27, 1984
- Decision Date
- April 18, 1984
- Product Code
- JLS
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JLS | Radioimmunoassay, Progesterone | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JLS), ordered by most recent decision date.
LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERONE IN SALIVA
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FDA Class 1
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PROGESTERONE ELISA
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FDA Class 1
·Clinical Chemistry
VITROS IMMUNODIAGNOSTICS PRODUCTS PROGESTERONE REAGENT PACK (GEM.1070), PROGESTERONE CALIBRATORS (GEM.C070)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
OPUS PROGESTERONE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ELECSYS PROGESTERONE ASSAY
FDA 510(k)
FDA Class 1
·Clinical Chemistry
VIDAS PROESTERONE (PRG) (30 409)
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Radioassay Systems Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K862204 | RSL (125I) ALDOSTERONE KIT | Sep 25, 1986 | Substantially Equivalent |
| K842960 | ANDROSTENEDIONE BY RIA | Sep 27, 1984 | Substantially Equivalent |
| K831855 | HATCH KIT | Jul 28, 1983 | Substantially Equivalent |
| K802195 | DEHYDROEPIANDROSTERONE SULFATE KIT RIA | Oct 23, 1980 | Substantially Equivalent |
| K800126 | RSL (125 L) PROGESTERONE KIT | Feb 13, 1980 | Substantially Equivalent |
| K791999 | (125I) TESTOSTERONE KIT | Oct 30, 1979 | Substantially Equivalent |
| K791651 | TOTAL ESTROGENS KIT BY RIA | Sep 27, 1979 | Substantially Equivalent |
| K791728 | RSL'S ASSAY PROCEDURE QUANTITATION | Sep 27, 1979 | Substantially Equivalent |
| K791740 | SERUM 11-DESOXYCORTISOL I AS TRACER | Sep 27, 1979 | Substantially Equivalent |
| K791835 | CORALENT COAT 125I CORTISOL RADIOIMM. | Sep 27, 1979 | Substantially Equivalent |